Biologically Focused Therapy of Treatment-Refractory MDS Patients

Sponsor

Stanford University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05245032

Collaborator

Notable Labs Inc. (Other)

Enrollment

Location

34.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This non interventional study examines the feasibility of using patient specific therapeutic screening method, ex vivo to enhance current treatment recommendations in a clinically feasible time frame of 30 days.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes

Detailed Description

This study utilizes the Notable Labs personalized testing service using an ex vivo assay, but does not involve actual treatment or treatment determinations. The results of these screenings will be made available to patients and their physicians for their use off study.

The primary objective of the study is:

• To determine the feasibility of selecting patient specific treatment regimens based on ex vivo within 30 days

The exploratory objectives of the study are:

• To identify biomarkers that explain ex vivo drug sensitivity results

Study Design

Study Type:

Observational

Anticipated Enrollment :

33 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Biologically Focused Therapy of Treatment Refractory MDS Patients

Actual Study Start Date :

Feb 18, 2020

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Feasibility testing During the screening visit, blood and/or a bone marrow sample will be obtained for the patient's standard clinical evaluation. An aliquot of the blood and/or marrow sample will be obtained for ex vivo drug sensitivity assay

Outcome Measures

Primary Outcome Measures

Proportion of patients with successful ex vivo results [30 days]
Proportion of patients with successful ex vivo results within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing
Proportion of patients with successful treatment decisions [30 days]
Proportion of patients with successful treatment decisions made by the molecular oncology board within a 30 day period from the time marrow sample is sent to Notable Labs for ex vivo testing

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Provide informed consent;
Myelodysplastic syndrome as defined by WHO classification (see Appendix 2), or MDS/MPN with >= 5% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML) 1 and 2 by WHO classification
Relapsed/refractory disease, defined as failed or are ineligible for hypomethylating agent therapy
Cytogenetics reported

Exclusion Criteria:

Hypoplastic MDS
Patients without adequate marrow samples for ex vivo analysis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford MDS Center	Stanford	California	United States	94304

Sponsors and Collaborators

Stanford University
Notable Labs Inc.

Investigators

Principal Investigator: Peter L Greerberg, Stanford Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT05245032

Other Study ID Numbers:

IRB-45236
HEMMDS0035
IRB-45236

First Posted:

Feb 17, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stanford University

MDS

Additional relevant MeSH terms:

Myelodysplastic Syndromes

Study Results

No Results Posted as of Aug 2, 2022